HANGZHOU Solution in Bicuspid AS Undergoing TAVR

Recruiting N/A Interventional Study
Aortic Stenosis Aortic Stenosis With Bicuspid Valve
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
60 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
508 (estimated)
Sponsor
Second Affiliated Hospital, Zhejiang University, School of Medicine · Other
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About This Trial

To compare supra-annular sizing and THV implantation technique (Hangzhou solution) versus annular sizing and THV implantation technique (control group) in bicuspid aortic stenosis (AS) patients undergoing transcatheter aortic valve replacement (TAVR) with self-expanding valves (SEVs): a randomized superiority trial

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Age ≥ 65 years * Age \<65 years and age ≥ 60 years with high surgical risk after combing STS Risk Estimate, Katz activities of Daily Living, major Organ System Dysfunction and Procedure-Specific Impediment; * Severe, bicuspid aortic stenosis: * Mean gradient ≥40 mmHg * Maximal…
Contacts

Jian'an Wang, PhD, MD

+86057187783777

wja@zju.edu.cn

CONTACT